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Production Workshop
Structured production capacity for repeat supply and customized manufacturing projects.
WELLEMPIRE · ABOUT US
Focused medical-care supply, built on manufacturing experience.
WellEmpire is the medical-care brand operated by Zhongshan Xinwei Weaving Co., Ltd. From our facility in Zhongshan, China, we develop and supply catheter securement products, CPAP headgear and rehabilitation accessories for direct purchase, wholesale and OEM/ODM projects.
BRANDWellEmpire
OPERATOR / MANUFACTURERZhongshan Xinwei Weaving Co., Ltd.
2009Founded
3,442 m²Facility
~70Employees
20+Production Machines
20+Patents
North America & EuropeCore Export Markets
OUR BRAND
One brand. Three focused care categories.
WellEmpire brings together medical fixation, respiratory-care accessories and rehabilitation support under one clear product architecture. The brand is supported by Zhongshan Xinwei Weaving Co., Ltd. for manufacturing, sourcing, private label, packaging and OEM/ODM projects.
PRODUCT FOCUS
Three sourcing categories, one consistent partner.
Each category has its own product requirements, but buyers work with the same WellEmpire team for sampling, specification review, customization and repeat supply.
01 · MEDICAL FIXATION
Catheter Securement
Securement products with different structures, material configurations, sizes and packaging options.
Explore collection →
02 · RESPIRATORY CARE
CPAP Headgear
Replacement and customized headgear built around fit, adjustment, materials and repeatable supply.
Explore collection →
03 · REHABILITATION
Rehabilitation Accessories
Mobility and care-support accessories for home care, elderly care and recovery applications.
Explore collection →MANUFACTURING ENVIRONMENT
From production to final inspection.
Real operating scenes help buyers understand how production, assembly, quality review and shipment preparation are organized.
02
Assembly & Finishing
03
Laboratory & Quality Control
04
Packaging & Final Inspection
OEM / ODM
Practical customization from sample to shipment.
Support is available for brands, distributors, medical-supply buyers and sourcing teams that need existing products adapted or new specifications developed.
Sample & Specification Matching
Work from customer samples, drawings, dimensions or technical requirements.
OEM Private Label
Customize logo, labels, pack quantities, color boxes, manuals and other brand presentation.
ODM Development
Adapt mature product platforms or develop new structures and tooling when required.
Packaging & Export Support
Prepare custom packaging, accessory kits and supporting export documentation.
TYPICAL LEAD TIMES
Timelines matched to project complexity.
1–3 DaysReady Stock
7–15 Working DaysStandard Custom Orders
15–30 Working DaysLarge / Complex Production
QUALITY & COMPLIANCE
Documentation with clear scope.
We present quality, material and regulatory documentation by its actual scope. A company registration, scope certificate or verification document does not mean that every WellEmpire product carries the same status. Confirm the exact SKU, intended use and destination market before ordering.
01Company identityDocuments are matched to Zhongshan Xinwei Weaving Co., Ltd. where applicable.
02Scope firstProduct, material and process scope is stated instead of using broad certification claims.
03SKU verificationProduct-specific regulatory status should be confirmed for the exact model before purchase.
REGULATORY DOCUMENTATION
Registration and verification files
View document
U.S. REGULATORY DOCUMENTATION2026
FDA Registration Service Documentation
Establishment registration and device-listing documentation for FDA FY 2026. This is not presented as FDA approval or certification of every product.
- Company
- Zhongshan Xinwei Weaving Co., Ltd.
- Registration No.
- 3039440874
- Issue / Update
- 2026-03-05
- Scope shown
- Medical fixation strips, catheter fixation devices and listed device categories/models
View supporting pages 3-page document
View document
EU / MDR-RELATED DOCUMENTATIONICR
Verification of Conformity
Voluntary verification covering the listed Medical Fixation Strap and Hook and Loop Strap models. The document itself states that it does not imply meeting all essential requirements.
- Document No.
- ICR/VC/HM250276
- Applicant / Manufacturer
- Zhongshan Xin Wei Weaving Co., Ltd.
- Reference
- MDR (EU) 2017/745 · EN ISO 10993-1:2020
- Validity shown
- 2025-02-24 to 2030-02-23
Scope note: Product status for sale in a specific EU market should be checked against the exact model and applicable regulatory pathway.
MATERIALS & SUSTAINABILITY
Material and supply-chain scope documents
View document
TEXTILE MATERIAL DOCUMENTATIONTESTEX
OEKO-TEX® STANDARD 100
Certificate for the defined hook-and-loop fastener material scope. It should not be interpreted as applying automatically to every WellEmpire medical product.
- Certificate
- BEAO 100280
- Scope
- Hook and loop fastener made of 100% polyamide, white or piece-dyed
- Product Class
- Class I (baby articles) - Annex 6
- Valid until
- 2026-09-15
View supporting page 2-page document
View document
SUSTAINABILITY DOCUMENTATIONSGS · GRS
Global Recycled Standard Scope Certificate
GRS scope certificate for the organization and listed process/product categories. The certificate states that product-level proof is provided by a valid transaction certificate.
- Scope Certificate
- SGC-GRC04428-GRS-2025-09
- Product category
- Functional accessories (PC0017)
- Processes
- Manufacturing (PR0016), Packing (PR0020)
- Valid until
- 2026-10-27
View supporting pages 3-page document
DOCUMENT REQUEST
Need documentation for supplier review?
Tell us the product, target market and document type you need. We can help identify the relevant file set for your sourcing review.
WORK WITH WELLEMPIRE
Start with the product, quantity and target market.
Share your requirements with Iris and our team can review product options, customization, packaging and project timing.